• Small Changes a One Year Protocol for Weight Management

  NCT02453854

  CompletedInterventionalNot ApplicableUpdated May 27, 2015
• Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial

  NCT04487158

  Unknown statusInterventionalNot ApplicableUpdated Jul 27, 2020
• Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults

  NCT02027077

  CompletedInterventionalNot ApplicableUpdated Jan 18, 2019
• Food, Activity and Behavior Trial

  NCT00640900

  Unknown statusInterventionalNot ApplicableUpdated Apr 1, 2008
• Comparison of Weight Management Programs Delivered in Large Versus Small Groups

  NCT02088749

  CompletedInterventionalNot ApplicableUpdated Jan 11, 2024
• Impact of Group Size in Weight Loss Interventions

  NCT01165151

  CompletedInterventionalPhase 4Updated Mar 6, 2015

ClinicalTrials.gov ID

NCT06668272

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

52Estimated

Last Update Posted

Oct 31, 2024Actual

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2025Estimated

Official Title

Small Changes Clinical Weight Loss Trial

Brief Summary

The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance

• Obesity

• Small Changes program
• Standard behavioral therapy for weight loss

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Body Mass Index greater than or equal to 25
• Stable weight with less than a 5% body weight change in the past 3 months.
• Willingness and ability to follow a written dietary plan.
• Ambulatory and capable of attending bi-weekly in-person and phone appointments.
• Must reside in the geographic area for the duration of the 12-week study.
• Clearance for weight loss by their health care provider.

Exclusion Criteria:

• Pregnant or lactating.
• Acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer.
• A history of bariatric surgery or gastrointestinal resection.
• Current use of anti-obesity medications or diabetes medications, such as Glucagon-like peptide-1 receptor agonists (GLP-1RAs), that induce weight loss.
• A history of commercial weight loss program participation within the last six months.
• A history of anorexia nervosa or other eating disorders.
• A history of anxiety or depression.
• Extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

nikhil.dhurandhar@ttu.edu806-834-6446